MAUDE Adverse Event Report: KAZ USA, INC., A HELEN OF TROY COMPANY VICKS; PERSONAL STEAM INHALER

Model Number	VIH200
Medical Device Problem Codes	Use of Device Problem (1670); Human-Device Interface Problem (2949); Device Handling Problem (3265); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); Full thickness (Third Degree) Burn (2696)
Date of Event	01/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Kaz usa, inc.Has requested that the product be returned to our company for testing, but it has not yet been received.
Event or Problem Description
A consumer reported that her she received a first-degree burn on her right thigh and a third-degree burn on her left thigh from hot water that spilled from the personal steam inhaler.She stated that she mistakenly grabbed it by the face mask instead of the body, causing the reservoir to fall off and splash hot water on both of her thighs, resulting in her injuries.Medical intervention was sought at an emergency room where the consumer was given antibiotics and had her legs wrapped.The instructions for proper use have clear warnings that state "caution: never move or disassemble the appliance while in use.It can spill hot water if tilted, shaken, or overturned which may lead to injury or burns.", as well as "the appliance should always be placed on a firm, flat, waterproof and heat resistant surface.Be sure the appliance is in a stable position and the power cord is out of the way to prevent the appliance from being overturned.".

• Brand Name: VICKS
• Common Device Name: PERSONAL STEAM INHALER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough MA 01752
• Manufacturer Contact: bethany lee ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752
• MDR Report Key: 21588797
• Report Number: 1314800-2025-00008
• Device Sequence Number: 21151166
• Product Code: KFZ
• UDI-Device Identifier: 00328785502008
• UDI-Public: 00328785502008
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: VIH200
• Device Lot Number: 20524
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female